FDA 483 OBSERVATION · #667 OF 1,000 MOST-CITED
Specifications met - identity, purity, strength, composition
FDA cited this observation 25 times across 22 firms in recent inspections. Below: how it breaks down by program area and fiscal year, and real examples of how FDA worded it on Form FDA 483.
How FDA worded it — real examples
You did not determine whether you met established product specifications for identity and composition of the finished batch of the dietary supplement.
You did not determine whether you met established product specifications for identity, purity, strength and composition of the finished batch of the dietary supplement.
You did not determine whether you met established product specifications for identity, purity, strength and composition of the finished batch of the dietary supplement.
You did not determine whether you met established product specifications for identity, purity, strength and composition of the finished batch of the dietary supplement.
You did not determine whether you met established product specifications for identity, purity, strength and composition of the finished batch of the dietary supplement.
You did not determine whether you met established product specifications for identity, purity, strength and composition of the finished batch of the dietary supplement.
Related SPEQ references
Where to read the requirements behind this observation area on SPEQ. These are SPEQ's topic and audience pages — not an FDA classification of the citation.
Examples are a representative sample of FDA's published inspection observations. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.
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